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Job ad: Regulatory Lead
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Regulatory Lead
Our team is now looking for a Regulatory Lead who will serve in the project team for a Nykode project in early clinical development.
The individual will lead, initiate and drive the many regulatory activities, including clinical trial applications and agency interactions and act as an active member of relevant clinical teams. You will ensure high quality documentation in regulatory submissions such as clinical trial applications, IND submissions, and meeting briefing packages and effectively manage associated timelines.
The responsibilities include:
- Developing and executing sound and robust global regulatory strategies, plans, and activities for Nykode’s products
- Actively participating in project teams and relevant trial teams Leading and coordinating regulatory activities with Regulatory CMC, documentation specialists, and relevant other internal and external parties Providing input and support to Quality, Preclinical, and Clinical activities and plans
